Early vector copy number determination and integration assessment for cell therapy using single-molecule PCR

Vector copy number (VCN) is a critical analytical parameter in cell therapy development, directly influencing product safety and potency. Conventional VCN workflows often require extended culturing to distinguish stable genomic integration from transient episomal vector, delaying process optimization and clone selection. Sensitive and low-variability methods that enable earlier integration assessment are needed. 

Single-molecule, multiplexed PCR provides precise and sensitive VCN determination while enabling early discrimination between episomal and integrated vector. This approach supports faster process optimization, earlier clone selection, and improved analytical confidence in cell therapy development workflows.

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